Diagnostic Performance of Noninvasive Fractional Flow Reserve From Computed Tomography (PERFECT)

Tongji University

Status and phase: Unknown; Phase 4

Conditions: Coronary Artery Disease

Treatments: Device: FFR (PressureWire)

Study type: Interventional

Funder types: Other

Identifiers

NCT01747317

TENTH1010

Details and patient eligibility

About

Fractional Flow Reserve derived from computed tomography(FFRCT) is a novel method for determining the physiologic significance of coronary artery disease (CAD), which will help physicians in clinical decision-making and decrease the medical cost, but its ability to identify patients with ischemia has not been adequately examined to date.

Full description

Fractional Flow Reserve derived from computed tomography(FFRCT) is a novel method for determining the physiologic significance of coronary artery disease (CAD), which will help physicians in clinical decision-making and decrease the medical cost, but its ability to identify patients with ischemia has not been adequately examined to date.

Available data from registered clinical trials has testified the diagnostic performance of FFRCT, but the diagnostic accuracy among them are not consistent.

Thus, the investigators designed a collaborative individual patient-data pooled-analysis aimed to assess the diagnostic accuracy of FFRCT and find the possible cause for inconsistency

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Coronary computed tomographic angiography(CCTA) with over 50 percent stenosis in a major coronary artery over 2mm diameter
• Undergoing clinically indicated invasive coronary angiography with FFR

Exclusion criteria

• A history of CABG surgery
• Prior percutaneous coronary intervention with suspected instent restenosis
• Suspicion of or recent acute coronary syndrome
• Complex congenital heart disease
• Prior pacemaker or defibrillator
• Prosthetic heart valve
• Significant arrhythmia
• heart rate >100 beats/min
• systolic blood pressure≤90 mmHg
• contraindication to beta blockers, nitroglycerin or adenosine
• Serum creatinine level greater than 1.5 mg per dL
• Allergy to iodinated contrast
• Pregnant state
• Body mass index greater than 35
• Evidence of active clinical instability or lifethreatening disease
• Canadian Cardiovascular Society class IV angina
• nonevaluable CCTA as determined by the CCTA core laboratory
• Inability to adhere to study procedures

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

Single arm study

Experimental group

Description:

Single arm study.The investigators will conduct computed tomography,angiography and FFR measurement during angiography in this single arm.

Treatment:

Device: FFR (PressureWire)